Early DiaGnosis of Anoxic Brain Injury for Resuscitated Patients

NCT03806660 | Suspended

• 1 other identifier: 2018-06Obs-CHRMT
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Sudden cardiac arrest (CA) in adults remains a major public health issue in industrialized countries, leading to a mortality rate greater than 90%. The analysis of French data estimates the number of sudden deaths at around 40,000 per year. The incidence rate for non-hospital CAs is 55 per 100,000 every year with an immediate survival rate of 9% and 4.8% at one year.

Conditions

Cardiac Arrest

Keywords

Cardiac Arrest; Coma; hypoxic brain damage; prognosis; neurological examination; pupillary reflex; electroencephalography; targeted temperature management; biomarkers; clinical score; evoked potentials

Outcome Measures

Primary Outcomes (1)

• Cerebral Performance Categories (CPC) score

  The Cerebral Performance Categories (CPC) score is evaluated by a physician at hospital discharge (CPC baseline assessed on basal statut before CA). Good neurological outcome defined as CPC \<3. CPC 1: no or minor disability (conscious and independent, able to work and lead a normal life. May have mild dysphasia, non-incapacitating hemiparesis, or minor cranial nerve abnormalities). CPC 2: Moderate disability (Conscious and independent, able to travel by public transport and work in sheltered environment, independent in activities of daily life. May have hemiplegia, seizures, ataxia, dysarthria or memory changes). Poor neurological outcome defined as CPC 3-5. CPC 3: severe disability (conscious but dependent, limited cognition, dementia, locked-in, minimally conscious. Usually in institution, but sometimes looked after at home with exceptional family effort). CPC 4: unconscious (persistent vegetative state). CPC 5: dead (certified brain dead or traditional criteria).

  Day 1

Secondary Outcomes (5)

• Cardiac Arrest Hospital Prognosis (CAHP) Score

  Day 1

• Pupillary light reflex surveillance with automated infrared pupillometry

  Day 1

• Neuron Specific Enolase (NSE) plasmatic levels

  Day 2

• Neuron Specific Enolase (NSE) plasmatic levels

  Day 3

• Amplitude-integrated electroencephalography (aEEG)

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Every major patient admitted in the Mercy Hospital CHR Metz-Thionville intensive care unit after CA

You may qualify if:

• Admission in Intensive Care Unit (ICU) following cardiac arrest with ROSC

You may not qualify if:

• Minor patient
• Cardiac arrest (CA) occuring in ICU
• Decision before ICU admission to withdraw life-sustaining treatments
• Patient with post-ROSC Glasgow Coma Score = 15

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz Thionville

Metz, 57085, France

Location

MeSH Terms

Conditions

Heart Arrest; Coma; Hypoxia, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: January 16, 2019
• Study Start: September 1, 2018
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: February 23, 2024

Record last verified: 2023-12

Locations

FR (1)